SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES


Device Classification Name

system, balloon, intra-aortic and control

510(k) Number K122628
Device Name SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES
Applicant
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield, 
NJ 
07004 -0011

Applicant Contact carla s cerqueira
Correspondent
DATASCOPE CORP., CARDIAC ASSIST DIVISION
15 law dr.
fairfield, 
NJ 
07004 -0011

Correspodent Contact carla s cerqueira
Regulation Number 870.3535
Classification Product Code
DSP  
Date Received 08/28/2012
Decision Date 09/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No